GlenMark Pharma - Sr Manager - Regulatory Affairs

Overall responsibilities for filing following applications (Drugs & Cosmetics ) to CDSCO within defined timelines and in accordance with established standards

- Phase III CT applications

- BA/BE Applications

- Marketing Authorizations

- Import license for the purpose of test and analysis (Form11)

- Import registration (Form40 & Form10)

Error free application and approvals in fast track manner

2 Overall responsibilities for filing following applications (Food products) to FSSAI within defined timelines and in accordance with established standards Ensure to get approvals for Food products 5.00 %

3 Overall responsibilities for filing following applications to DDA NEPAL for new registration & renewal registration within defined timelines and in accordance with established standards Ensue to get Marketing Authorization approvals 5.00 %

4 Overall responsibilities for filing following applications for product registration & to MOH of MENA region within defined timelines and in accordance with established standards Ensue to get Marketing Authorization approvals 10.00 %

5 Coordination with DCO team for follow-up with CDSCO regarding submitted applications To track the status at CDSCO office 5.00 %

6 Develop an understanding of the importance of life cycle management and how key regulatory strategies / activities can fulfill commercial needs and maximize the value of Company assets.

Provide regulatory inputs to BD & R&D to provide suitable regulatory strategy or regulatory pathway for formulation products (including OTC products) including Nepal & MENA

In addition, provide technical support to R&D, CQA, PDC, and PPIC teams to resolve their technical/regulatory queries

To launch product as per targeted timelines 15.00 %

7 To review & ensure timely submission of supportive documents to NDAC referral Ensure to get positive recommendation 5.00 %

8 Review of Artworks for India Formulation Artworks, Nepal & MENA To ensure labeling requirements 5.00 %

9 Review of change control for India Formulation Artworks, Nepal & MENA Major changes can be intimated to Regulatory Authority 5.00 %

10 Ensure periodic updates - Register database Support register data base team 5.00 %

11 Providing comments on draft gazette notifications & draft guidelines published by CDSCO To get clarity from Regulators 5.00 %

12 Circulating notifications published by CDSCO; IPC; NPPA & Phrmaexcil In order to maintain regulatory compliance in product life cycle and ensure the complaints are less. 5.00 %